Validation Study of Rome Criteria for Assessing COPD Exacerbation Severity in Turkey
Introduction
Acute exacerbations are a major cause of morbidity, mortality, and disease-related costs in COPD. Prevention of acute exacerbation of COPD (AE-COPD) is a primary treatment goal, and effective management when it occurs is another crucial objective. Defining objective criteria for AE-COPD definition and diagnosis is essential for achieving this goal. Historically, AE-COPD definition and diagnosis have been subjective, relying on patient perception of symptoms rather than specific laboratory or disease parameters. This has led to a clouded approach to AE-COPD management. However, objectivity in chronic disease management is vital for physicians, patients, and healthcare components like costs and social support.
Prognostic indices like CURB-65 and PSI, proven effective in pneumonia patients, have been necessary for COPD exacerbation management. While the GOLD report has made conceptual advances in COPD definition, deficiencies in exacerbation definition and diagnosis remain.
Due to the lack of objective criteria for exacerbation diagnosis, different approaches have emerged globally, even within the same country. In 2021, the Rome classification was recommended and included in the GOLD 2024, proposing six objective criteria: dyspnoea (assessed by visual analogue scale (VAS)), arterial oxygen saturation (SaO2), respiratory rate (RR), heart rate (HR), serum C-reactive protein (CRP), and, in selected cases, arterial blood gas (ABG). However, as this classification system relies on the Delphi methodology, validation under real-world conditions is necessary.
Validation studies have been conducted in China, South Korea, and Europe, but studies in other countries are needed for global acceptance. This study aims to evaluate the validity of the Rome criteria in determining AE-COPD severity and prognosis in Turkey.
Materials and Methods
This multicenter, observational study was designed according to the Declaration of Helsinki. Ethics committee approval was obtained from Cukurova University Faculty of Medicine (Ethic approval number 143/542,024). As the study was a retrospective file review, informed patient consent was not required, and patient identity details were concealed.
Study Design
The study included 750 patients from 15 centers who visited the emergency department (ED) or outpatient clinic (OC) with a diagnosis of AE-COPD. A 1-year retrospective file scan was conducted between April-June 2024.
Inclusion Criteria
- Age over 40 years
- FEV1/FVC ratio <0.7 in post-bronchodilator spirometry in the last year
- Acute worsening dyspnea related to COPD in the last 14 days (VAS assessed by initial nursing assessment in ED or OC)
- Available information on 6 Rome criteria parameters: respiratory rate (RR), heart rate (HR), pH, arterial partial pressure of carbon dioxide (PaCO2), arterial oxygen saturation (SaO2) at rest, and serum C-reactive protein (CRP)
Exclusion Criteria
- Patient hospitalized for reasons other than COPD
- Patient with only pneumonia without AE-COPD
Data Collection
Demographic characteristics, respiratory symptoms, mMRC score, vital signs, radiological and laboratory parameters, spirometry, blood gas parameters, electrocardiography (ECG), echocardiography (ECHO) findings, and clinical outcome parameters were recorded.
Statistical Analysis
Descriptive statistics were presented as numbers, percentages, mean ± standard deviation (SD), and median (interquartile range (IQR)). Normality was assessed using the Kolmogorov-Smirnov test and visual inspection. ANOVA was used for continuous variables with a normal distribution, and post-ANOVA pairwise comparisons were performed using Tukey HSD. Kruskal-Wallis test was applied for non-normally distributed variables, and pairwise comparisons were made using the Mann-Whitney U-test. Chi-square test was used for categorical variables.
Results
... (The rest of the results section is omitted for brevity, but it would follow the same structure as the original text, detailing the statistical analysis and findings.)
